BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2873111 · Received December 13, 2012

    Report

    Report Number
    1644487-2012-03349
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    January 1, 2007
    Report Date
    November 13, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED IN CLINIC NOTES THAT THE PATIENT HAD IRREGULAR AND RAPID HEARTBEAT, NOT RELATIONSHIP TO VNS PROVIDED. THE CLINIC NOTES ARE FROM THE PATIENT CURRENT NEUROLOGIST. THE PATIENT'S PREVIOUS NEUROLOGIST REPORTED THAT A PAST CARDIOLOGIST OF THE PATIENT FELT THE ARRHYTHMIAS WERE RELATED TO VNS BUT HE DID NOT FEEL THE ARRHYTHMIAS WERE RELATED TO VNS AS THE PATIENT HAD A HISTORY OF ARRHYTHMIAS PRIOR TO VNS. IT IS CURRENTLY UNKNOWN WHO THE PATIENT'S CURRENT CARDIOLOGIST IS OR THEIR ASSESSMENT ON THE RELATIONSHIP OF THE ARRHYTHMIAS TO VNS. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT THE CURRENTLY TREATING PHYSICIAN HAS NO INFORMATION TO PROVIDE REGARDING THE REPORTED ARRHYTHMIAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 015709

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other